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Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A

NCT ID: NCT02256917

Last Updated: 2021-01-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-09-30

Brief Summary

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The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.

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Detailed Description

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Conditions

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Severe Haemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Human-cl rhFVIII

Group Type EXPERIMENTAL

Human cl rhFVIII

Intervention Type BIOLOGICAL

Interventions

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Human cl rhFVIII

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Severe Haemophilia A (FVIII:C \< 1%)
* Male patients \>= 18 years of age
* Previous treatment with a FVIII concentrate for at least 150 EDs
* Good documentation regarding dosing and bleeding frequency in the 6 months preceding study start
* Immunocompetence (CD4+ count \> 200/uL)

Exclusion Criteria

* Any coagulation disorder other than Haemophilia A
* Present of past FVIII inhibitor activity
* Severe liver or kidney disease
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Octapharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Craig M Kessler, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Octapharma Research Site

Sacramento, California, United States

Site Status

Octapharma Research Site

Aurora, Colorado, United States

Site Status

Octapharma Research Site

Washington D.C., District of Columbia, United States

Site Status

Octapharma Research Site

Miami, Florida, United States

Site Status

Octapharma Research Site

Chicago, Illinois, United States

Site Status

Octapharma Research Site

Indianapolis, Indiana, United States

Site Status

Octapharma Research Site

Memphis, Tennessee, United States

Site Status

Octapharma Research Site

Houston, Texas, United States

Site Status

Octapharma Research Site

Salt Lake City, Utah, United States

Site Status

Octapharma Research Site

Edmonton, Alberta, Canada

Site Status

Octapharma Research Site

St. John's, Newfoundland and Labrador, Canada

Site Status

McMaster University

Hamilton, Ontario, Canada

Site Status

University Hospital Centre Zagreb

Zagreb, , Croatia

Site Status

Helsinki University Hospital

Helsinki, , Finland

Site Status

Centre Régional de Traitement de l'Hémophilie

Bron, , France

Site Status

CHU Estaing

Clermont-Ferrand, , France

Site Status

Centre Hospitalier Universitaire Félix Guyon

La Réunion, , France

Site Status

Centre Régional de Traitement de l'hémophilie

Nantes, , France

Site Status

Hôpital Purpan - Centre de Traitment Regional de l'Hemophilie Pole

Toulouse, , France

Site Status

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Hospital of the Univ of Occupational and Environmental Health

Kitakyushu, Fukuoka, Japan

Site Status

St. Marianna Univ School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Site Status

Nara Medical University Hospital

Kashihara, Nara, Japan

Site Status

Gunma University Hospital

Maebashi, , Japan

Site Status

Osaka National Hospital

Osaka, , Japan

Site Status

Ogikubo Hospital

Tokyo, , Japan

Site Status

Teikyo University Hospital

Tokyo, , Japan

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

PHI Institute of Transfusion Medicine of Republic of Macedonia

Skopje, , North Macedonia

Site Status

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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United States Canada Croatia Finland France Japan Netherlands North Macedonia Slovenia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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GENA-21B

Identifier Type: -

Identifier Source: org_study_id

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